Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on March 3, 2023, Fresenius Kidney Care Chadds Ford, was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services-Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on March 3, 2023, Fresenius Kidney Care Chadds Ford, was identified to have the following standard level deficiencies, and was determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.30(a)(4)(ii) STANDARD
IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL
Name - Component - 00
[The facility must demonstrate that it follows standard infection control precautions by implementing-
(4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-]
(ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment.
Observations:
Based upon observation, policy and procedure review, and an interview with the facility administrator, it was determined the ESRD failed to ensure the disinfection of the in-center hemodialysis machine, was conducted per ESRD policy, for five (5) of twelve (12) in-center hemodialysis (HD) machines (HD Machine #1-HD Machine #5/ Observation #4) and failed to ensure the disinfection of non-disposable equipment after patient usage for two (2) of two (2) Nursing Assessment observations (Observation #5 and Observation #6).
Findings include:
Review of policy "Cleaning and Disinfection of the Dialysis Station" on 3/3/23 at approximately 11:05 AM states "....After use, any non-disposable equipment and supplies brought into the dialysis station (ex. stethoscope) must be disinfected with 1:100 bleach or EPA registered disinfectant before being removed from the dialysis station.....To prevent cross-contamination between patients, it is important that the previous patient completely vacate the station before staff begin cleaning and disinfection of the station and set up for the next patient."
Observation #4: On 2/27/2023, at approximately 10:30 AM, the hemodialysis machines at Station #1-Station #5 were noted to have unused saturated cleaning clothes resting on the sides of the machine, while patients were actively receiving dialysis treatments at each station.
Observation #5 and Observation #6: On 2/27/2023, at approximately 1:10 PM, RN#1 was observed performing a patient assessment at Station #2, utilizing a Stethoscope #1. RN#1 did not disinfect Stethoscope #1 upon completion of the patient assessment, then proceeded to perform a patient assessment at Station #12 utilizing Stethoscope #1 and did disinfect Stethoscope #1 upon completion of the patient assessment.
An interview with the ESRD administrator on 2/27/2023 at approximately 2:30 PM confirmed the above findings.
Plan of Correction:To ensure compliance the Charge Nurse (CN) or designee will in-service all the direct patient care (DPC) staff on the following policies:
- Cleaning and Disinfection of the Dialysis Station
The meeting will focus on ensuring that all non-disposable items, including stethoscopes, taken into the patient station must be cleaned and disinfected prior to leaving the station or before use on another patient. The meeting will also reinforce that no cleaning wipes may be left on the machines at any time. The wetted wipes must be used immediately when brought to the station and then disposed of after use.
Inservicing will be completed by March 20, 2023. All training documentation is on file at the facility.
The CN or designee will perform daily audits for two (2) weeks. At that time if compliance is observed the audits will then be completed 2/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A plan of correction (POC) specific audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The Facility Administrator (FA) will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: April 21, 2023
494.30(c)(2) STANDARD
IC-CATHETERS:GENERAL
Name - Component - 00
(2) The "Guidelines for the Prevention of Intravascular Catheter-Related Infections" entitled "Recommendations for Placement of Intravascular Catheters in Adults and Children" parts I - IV; and "Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients," Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html
Observations:
Based upon observation, policy and procedure review, and an interview with the facility administrator, it was determined the ESRD failed to ensure the disinfection of Central Venous Catheter (CVC) hubs, was conducted per ESRD policy, for two (2) of two (2) observations of initiation of dialysis with a CVC (Observation #1 and Observation #2) and one (1) of two (2) observations of discontinuation of dialysis with a CVC (Observation #3).
Findings include:
Review of policy "Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer" on 3/3/23 at approximately 11:00 AM states "....Follow the steps below to disinfect the catheter connections: Threads and end of the luer lock (hub) must be scrubbed with 70% alcohol pad (or other antiseptic such as chlorhexidine, povidone if required by the hospital) for 10-15 seconds and any time caps are removed, or bloodlines are disconnected (i.e. end of treatment or treatment interruption) to reduce risk of contamination."
Observation #1: On 2/27/2023, at approximately 11:40 AM at Station #1 , PCT #1 was observed disinfecting the catheter hubs for 3 seconds, not 10-15 seconds per ESRD policy.
Observation #2: On 2/27/2023, at approximately 12:00 PM, AM at Station #3 , PCT #1 was observed disinfecting the catheter hubs for 3 seconds, not 10-15 seconds per ESRD policy.
Observation #3: On 2/27/2023, at approximately 12:50 PM, AM at Station #3 , PCT #1 was observed disinfecting the catheter hubs for 3 seconds, not 10-15 seconds per ESRD policy.
An interview with the ESRD administrator on 2/27/2023 at approximately 2:30 PM confirmed the above findings.
Plan of Correction:To ensure compliance the Charge Nurse (CN) or designee will in-service all DPC staff on the following policy:
- Initiation of Treatment Using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer
The meeting will emphasize that all staff must ensure that strict infection control practices per policy are adhered to when caring for a patient with a CVC. The meeting will reinforce that the patient's CVC hubs and threads are scrubbed for a full 10-15 seconds anytime the caps are removed and when bloodlines are disconnected.
Inservicing will be completed by March 20, 2023, with documentation of the training on file at the facility.
The CN or designee will perform daily audits for 2 weeks. At that time if compliance is observed, the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly QAPI schedule. A POC audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The Facility Administrator (FA) will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: April 21, 2023
494.90(a)(5) STANDARD
POC-VASCULAR ACCESS-MONITOR/REFERRALS
Name - Component - 00
The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement.
Observations:
Based upon observation, policy and procedure review, and an interview with the facility administrator, it was determined the ESRD failed to ensure the patient's access site was cleansed per ESRD policy, prior to treatment, for one (1) of two (2) observations of Access of AV Fistula/Graft for Initiation of Dialysis (Observation #7).
Findings include:
Review of policy "Access Assessment and Cannulation" on 3/3/23 at approximately 11:10 AM states "....Prior to treatment, ask patient to wash access area with soap per hand hygiene procedure. Wash access (per above) if patients unable to clean their access..."
Observation #7: On 2/27/2023, at approximately 12:30 PM at Station #2 , PCT #1 was observed initiating dialysis treatment, while neither the patient nor PCT#1 had washed the access prior.
An interview with the ESRD administrator on 2/27/2023 at approximately 2:30 PM confirmed the above findings.
Plan of Correction:The Charge Nurse (CN) or designee educated all the DPC staff on the following policy:
- Access Assessment and Cannulation
The meeting will reinforce the importance of ensuring that the patient's access is washed with soap and water prior to the access evaluation. Emphasis will be placed on ensuring that patients wash their access sites. The meeting will reinforce that the DPC staff must ask the patient if the site was washed and if not, the DPC staff are to wash the site with soap and water for them.
The in-servicing will be completed by March 20, 2023. Documentation of the training will be on file at the facility.
The CN or designee will perform daily audits for 2 weeks. At that time if compliance is observed the audits will then be completed 2/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly QAPI schedule. A POC specific audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The Facility Administrator (FA) will review the audits and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: April 21, 2023
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